This is a summary of the European public assessment report (EPAR) for Tovanor Breezhaler. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tovanor Breezhaler.
- What is Tovanor Breezhaler?
Tovanor Breezhaler is a medicine that contains the active substance glycopyrronium bromide. It is available as capsules containing a powder for inhalation.
- What is Tovanor Breezhaler used for?
Tovanor Breezhaler is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Tovanor Breezhaler is used for maintenance (regular) treatment.
The medicine can only be obtained with a prescription.
- How is Tovanor Breezhaler used?
Tovanor Breezhaler capsules are only used with the Tovanor Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes the powder contained in the capsule in through the mouth. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.
The recommended dose is one capsule once a day at the same time each day. Patients should not take more than one capsule in a day.
- How does Tovanor Breezhaler work?
Tovanor Breezhaler is an anticholinergic bronchodilator. This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic receptors, which control the contraction of muscles. When the active substance in Tovanor Breezhaler, glycopyrronium bromide, is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
- How has Tovanor Breezhaler been studied?
The effects of Tovanor Breezhaler were first tested in experimental models before being studied in humans.
Tovanor Breezhaler has been studied in two main studies involving a total of 1,888 patients with COPD, where Tovanor Breezhaler was compared with placebo (a dummy treatment). In both studies, the main measure of effectiveness was how Tovanor Breezhaler improved patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks of treatment.
- What benefit has Tovanor Breezhaler shown during the studies?
Tovanor Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD: after 12 weeks of treatment, the increase in FEV1 with Tovanor Breezhaler was 97 ml more than with placebo in the first study and 108 ml more in the second study.
- What is the risk associated with Tovanor Breezhaler?
The most common side effects with Tovanor Breezhaler (seen in between 1 and 10 patients in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping) and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects reported with Tovanor Breezhaler, see the package leaflet.
Tovanor Breezhaler must not be used in people who are hypersensitive (allergic) to glycopyrronium bromide or any of the other ingredients.
- Why has Tovanor Breezhaler been approved?
The CHMP noted that Tovanor Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD. The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment. In addition, there were no major safety concerns with Tovanor Breezhaler, with side effects being similar to other anticholinergic bronchodilator medicines. Therefore, the CHMP decided that Tovanor Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- What measures are being taken to ensure the safe use of Tovanor Breezhaler?
As anticholinergic bronchodilator medicines may have an effect on the heart and blood vessels, the company will continue to closely monitor the medicine’s cardiovascular effects and will carry out a further study in patients to identify any potential risks.
- Other information about Tovanor Breezhaler
The European Commission granted a marketing authorisation valid throughout the European Union for Tovanor Breezhaler on 28 September 2012.
For more information about treatment with Tovanor Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 22/11/2016 .
15/09/2016 Tovanor Breezhaler -EMEA/H/C/002690 -WS-1001
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Drugs for obstructive airway diseases
Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Tovanor Breezhaler : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||2013-08-09||2016-11-22|
|Tovanor Breezhaler-H-C-2690-PSUV-0004 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)||SV = svenska||2016-05-25|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Tovanor Breezhaler : EPAR - Public assessment report||SV = svenska||2012-10-17|
|CHMP summary of positive opinion for Tovanor Breezhaler||SV = svenska||2012-06-22||2012-08-07|
This medicine is approved for use in the European Union